GUEST COLUMNISTS

• Cell and Gene Therapies Are Driving Investment Opportunities

  As technology advances in cell and gene therapy and investment continues in these technologies, life-changing and life-saving neurological therapies are an option available to anyone who needs it.

• FDA Steps Up Support For Advanced Manufacturing Technologies

  In its latest move to encourage the broader adoption of advanced manufacturing technologies, the FDA has entered into a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) that combines the strength of FDA’s regulatory expertise and NIST’s globally recognized precision characterization and standards. The MOU is significant because it takes the next step in providing much-needed guidance and resources to the industry.

• Answer These 3 Questions Before Developing Software As A Medical Device

  Whether your organization is interested in software adoption to build in continuous data acquisition, offer remote care capabilities, improve patient engagement, or simplify routine clinical tasks, software as a medical device (SaMD) is at the center of it. Before getting started on your SaMD project, answer these three questions.

• FDA’s COVID-19 PREPP Initiative Summary Report — Key Takeaways For Manufacturers

  Published in January 2021, the FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative Summary Report is the culmination of work performed by the FDA’s PREPP Initiative, which launched in April 2020 to examine lessons learned from the agency’s response to the global COVID-19 pandemic. This article provides a brief overview of the report’s overarching themes and highlights key regulatory insights for manufacturers in light of two action areas in particular.

• Philadelphia’s Talent Pipeline Collaborative Readies Region For Cell And Gene Therapy Job Growth

  On the heels of a 2020 study predicting substantial job growth in the cell and gene therapy sector in Greater Philadelphia, industry leaders in our region have created the Life Science Talent Pipeline Collaborative to ensure a strong talent pool for the future. 

• Risk Intelligence And Risk-Based Decision-Making: Combining Strategic Risk Management With Safety Risk Management

  You’re familiar with ISO 14971, the “Application of Risk Management to Medical Devices” standard. Upon closer inspection, you’ll learn that this standard is in fact a standard for medical device safety risk management. However, risk management goes beyond the product safety aspects and includes strategic and operational elements. This article discusses how risk managed at one level allows for opportunities for value creation at other levels.

• The BPCIA And Declaratory Judgment: The Real Dance Partners?

  In theory, the initial exchange process in the first phase of litigation is intended to whittle down the number of patents and initiate resolution of any disputes during FDA review of the aBLA. However, despite its high-minded objectives, litigation under the BPCIA has proven less harmonious than planned. 

• Developing Future Delivery Models For ATMPs: Practical Considerations

  With a small number of approved cell therapies/ex-vivo gene therapies, and with those approved therapies reaching small patient populations, there is not a proven strategy to answer the questions about large-scale commercial manufacturing. The developers of these processes are taking different strategies for commercial manufacturing as they weigh several factors.